Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window

NCT06560203 | Recruiting DMC

• 1 other identifier: BAOCHE-2
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

Conditions

Acute Ischemic Stroke; Basilar Artery Occlusion

Keywords

Mechanical thrombectomy; Extended time window

Outcome Measures

Primary Outcomes (1)

• Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days

  The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])

  90 days

Secondary Outcomes (8)

• Dramatic early favorable response

  24 (-2/+12) hours

• Dichotomized mRS score (0-2 versus 3-6 )

  90 days

• Ordinal Shift analysis of mRS at 90 days

  90 days

• Barthel Index at 90 days

  90 days

• Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)

  90 days

Other Outcomes (3)

• Mortality

  90 days

• Symptomatic intracranial hemorrhage

  24-72 hours

• Serious adverse events (SAE)

  90 days, 12 months, during follow-up

Study Arms (2)

mechanical thrombectomy group

EXPERIMENTAL

Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.

Procedure: Mechanical thrombectomy

best medical management agroup

NO INTERVENTION

Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.

Interventions

Mechanical thrombectomy PROCEDURE

Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.

mechanical thrombectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.
• Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
• Age ≥18 and ≤ 80.
• Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
• No significant pre-stroke functional disability (mRS ≤ 1).
• Patient treatable within 72 hours of symptom onset. Symptom onset is defined as the point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history.
• Informed consent obtained from patient or authorized patient surrogate

You may not qualify if:

• Clinical criteria
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
• Baseline platelet count \< 50000/µL.
• Baseline blood glucose of \< 50mg/dL or \>400mg/dl.
• Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
• Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life threatening allergy (more than rash) to contrast medium.
• Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
• Renal insufficiency with creatinine ≥ 3 mg/dl.
• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Known diagnosis or clinical suspicion of cerebral vasculitis.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (13)

• Jovin TG, Li C, Wu L, Wu C, Chen J, Jiang C, Shi Z, Gao Z, Song C, Chen W, Peng Y, Yao C, Wei M, Li T, Wei L, Xiao G, Yang H, Ren M, Duan J, Liu X, Yang Q, Liu Y, Zhu Q, Shi W, Zhu Q, Li X, Guo Z, Yang Q, Hou C, Zhao W, Ma Q, Zhang Y, Jiao L, Zhang H, Liebeskind DS, Liang H, Jadhav AP, Wen C, Brown S, Zhu L, Ye H, Ribo M, Chang M, Song H, Chen J, Ji X; BAOCHE Investigators. Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1373-1384. doi: 10.1056/NEJMoa2207576.

  PMID: 36239645 RESULT

• Tao C, Nogueira RG, Zhu Y, Sun J, Han H, Yuan G, Wen C, Zhou P, Chen W, Zeng G, Li Y, Ma Z, Yu C, Su J, Zhou Z, Chen Z, Liao G, Sun Y, Ren Y, Zhang H, Chen J, Yue X, Xiao G, Wang L, Liu R, Liu W, Liu Y, Wang L, Zhang C, Liu T, Song J, Li R, Xu P, Yin Y, Wang G, Baxter B, Qureshi AI, Liu X, Hu W; ATTENTION Investigators. Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1361-1372. doi: 10.1056/NEJMoa2206317.

  PMID: 36239644 RESULT

• Kobeissi H, Ghozy S, Adusumilli G, Kadirvel R, Brinjikji W, Rabinstein AA, Kallmes DF. Endovascular Therapy for Stroke Presenting Beyond 24 Hours: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 May 1;6(5):e2311768. doi: 10.1001/jamanetworkopen.2023.11768.

  PMID: 37140919 RESULT

• Purrucker JC, Ringleb PA, Seker F, Potreck A, Nagel S, Schonenberger S, Berberich A, Neuberger U, Mohlenbruch M, Weyland C. Leaving the day behind: endovascular therapy beyond 24 h in acute stroke of the anterior and posterior circulation. Ther Adv Neurol Disord. 2022 May 25;15:17562864221101083. doi: 10.1177/17562864221101083. eCollection 2022.

  PMID: 35646160 RESULT

• Pandhi A, Chandra R, Abdulrazzak MA, Alrohimi A, Mahapatra A, Bain M, Moore N, Hussain MS, Bullen J, Toth G. Mechanical thrombectomy for acute large vessel occlusion stroke beyond 24 h. J Neurol Sci. 2023 Apr 15;447:120594. doi: 10.1016/j.jns.2023.120594. Epub 2023 Mar 2.

  PMID: 36893513 RESULT

• Markus HS. Reperfusion therapy for stroke: From improving global access, to thrombectomy beyond 24 hours. Int J Stroke. 2024 Mar;19(3):248-250. doi: 10.1177/17474930241232131. No abstract available.

  PMID: 38420839 RESULT

• Dhillon PS, Butt W, Podlasek A, Barrett E, McConachie N, Lenthall R, Nair S, Malik L, James MA, Dineen RA, England TJ. Endovascular thrombectomy beyond 24 hours from ischemic stroke onset: a propensity score matched cohort study. J Neurointerv Surg. 2023 Mar;15(3):233-237. doi: 10.1136/neurintsurg-2021-018591. Epub 2022 Feb 15.

  PMID: 35169031 RESULT

• Rodriguez-Calienes A, Galecio-Castillo M, Vivanco-Suarez J, Mohamed GA, Toth G, Sarraj A, Pujara D, Chowdhury AA, Farooqui M, Ghannam M, Samaniego EA, Jovin TG, Ortega-Gutierrez S. Endovascular thrombectomy beyond 24 hours from last known well: a systematic review with meta-analysis. J Neurointerv Surg. 2024 Jun 17;16(7):670-676. doi: 10.1136/jnis-2023-020443.

  PMID: 37355251 RESULT

• Shaban A, Al Kasab S, Chalhoub RM, Bass E, Maier I, Psychogios MN, Alawieh A, Wolfe SQ, Arthur AS, Dumont TM, Kan P, Kim JT, De Leacy R, Osbun JW, Rai AT, Jabbour P, Park MS, Crosa RJ, Mascitelli JR, Levitt MR, Polifka AJ, Casagrande W, Yoshimura S, Matouk C, Williamson R, Gory B, Mokin M, Fragata I, Romano DG, Chowdhry SA, Moss M, Behme D, Limaye K, Spiotta AM, Samaniego EA. Mechanical thrombectomy for large vessel occlusion strokes beyond 24 hours. J Neurointerv Surg. 2023 Dec 21;15(e3):e331-e336. doi: 10.1136/jnis-2022-019372.

  PMID: 36593118 RESULT

• Liu S, Cao W, Wu L, Wen A, Zhou Y, Xiang Z, Rao W, Yao D. Endovascular treatment over 24 hours after ischemic stroke onset: a single-center retrospective study. Neuroradiology. 2023 Apr;65(4):793-804. doi: 10.1007/s00234-022-03105-6. Epub 2022 Dec 23.

  PMID: 36550266 RESULT

• Mohamed GA, Nogueira RG, Essibayi MA, Aboul-Nour H, Mohammaden M, Haussen DC, Ruiz AM, Gross BA, Kuybu O, Salem MM, Burkhardt JK, Jankowitz B, Siegler JE, Patel P, Hester T, Ortega-Gutierrez S, Farooqui M, Galecio-Castillo M, Nguyen TN, Abdalkader M, Klein P, Charles JH, Saini V, Yavagal DR, Jumah A, Alaraj A, Peng S, Hafeez M, Tanweer O, Kan P, Scaggiante J, Matsoukas S, Fifi JT, Mayer SA, Chebl AB. Tissue Clock Beyond Time Clock: Endovascular Thrombectomy for Patients With Large Vessel Occlusion Stroke Beyond 24 Hours. J Stroke. 2023 May;25(2):282-290. doi: 10.5853/jos.2023.00017. Epub 2023 May 30.

  PMID: 37282375 RESULT

• Sarraj A, Mlynash M, Heit J, Pujara D, Lansberg M, Marks M, Albers GW. Clinical Outcomes and Identification of Patients With Persistent Penumbral Profiles Beyond 24 Hours From Last Known Well: Analysis From DEFUSE 3. Stroke. 2021 Mar;52(3):838-849. doi: 10.1161/STROKEAHA.120.031147. Epub 2021 Feb 10.

  PMID: 33563012 RESULT

• Christensen S, Mlynash M, Kemp S, Yennu A, Heit JJ, Marks MP, Lansberg MG, Albers GW. Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3. Stroke. 2019 Mar;50(3):754-757. doi: 10.1161/STROKEAHA.118.023392.

  PMID: 30735466 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji

CONTACT

01083198962; jixm@ccmu.edu

Chuanhui Li

CONTACT

15210439828; lichuanhui365@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)